Regimen-related toxicity in 96 patients
. | Grade, n (%) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
| Toxicity . | Grade I . | Grade II . | Grade III . | Grade IV . | |||
| Liver | |||||||
| Transaminase elevation | 46 (48) | 12 (13) | 15 (16) | 2 (2) | |||
| Bilirubin elevation | 24 (25) | 11 (12) | 7 (7) | 2 (2) | |||
| VOD,† moderate | 2 (2) | — | — | — | |||
| Alkaline phosphatase elevation | 42 (44) | 1 (1) | 0 | 0 | |||
| Gastrointestinal tract | |||||||
| Diarrhea | 25 (26) | 2 (2) | 2 (2) | 0 | |||
| Nausea and vomiting | 47 (49) | 6 (6) | 1 (1) | 0 | |||
| Mucositis | 24 (25) | 59 (61) | 9 (9) | 0 | |||
| Hypoalbuminemia | 16 (17) | 61 (63) | 2 (2) | 0 | |||
| Abdominal pain | 5 (5) | 6 (6) | 1 (1) | 0 | |||
| Urinary tract/kidney | |||||||
| Creatinine elevation | 20 (21) | 4 (4) | 0 | 0 | |||
| Hemorrhagic cystitis | 0 | 2 (2) | 3 (3) | 0 | |||
| Skin | |||||||
| Hand-foot syndrome | 0 | 2 (2) | 2 (2) | 0 | |||
| Rash | 4 (4) | 1 (1) | 0 | 0 | |||
| Neurologic | |||||||
| Peripheral neuropathy | 4 (4) | 3 (3) | 0 | 0 | |||
| Headache | 4 (4) | 2 (2) | 0 | 0 | |||
| Mental status changes | 0 | 1 (1) | 0 | 0 | |||
| Seizures‡ | 1 (1) | 0 | 0 | 0 | |||
| Pulmonary/pleural | |||||||
| Pleural effusion | 1 (1) | 2 (2) | 0 | 0 | |||
| Pulmonary hemorrhage | 0 | 0 | 1 (1) | 0 | |||
| Pulmonary edema | 0 | 2 (2) | 0 | 0 | |||
| Electrolyte disturbance | 123 (100) | 42 (44) | 4 (4) | 0 | |||
| Hyperglycemia | 2 (2) | 6 (6) | 5 (5) | 0 | |||
| Cardiovascular | |||||||
| Hypertension | 4 (4) | 0 | 3 (3) | 0 | |||
| Hypotension | 2 (2) | 0 | 1 (1) | 0 | |||
| Arrhythmia | 2 (2) | 0 | 0 | 0 | |||
| Pericardial effusion | 0 | 0 | 1 (1) | 0 | |||
| Decreased LEVF | 0 | 0 | 2 (2) | 0 | |||
| Flulike symptoms/ATG-related symptoms | 3 (3) | 3 (3) | 1 (1) | 0 | |||
. | Grade, n (%) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
| Toxicity . | Grade I . | Grade II . | Grade III . | Grade IV . | |||
| Liver | |||||||
| Transaminase elevation | 46 (48) | 12 (13) | 15 (16) | 2 (2) | |||
| Bilirubin elevation | 24 (25) | 11 (12) | 7 (7) | 2 (2) | |||
| VOD,† moderate | 2 (2) | — | — | — | |||
| Alkaline phosphatase elevation | 42 (44) | 1 (1) | 0 | 0 | |||
| Gastrointestinal tract | |||||||
| Diarrhea | 25 (26) | 2 (2) | 2 (2) | 0 | |||
| Nausea and vomiting | 47 (49) | 6 (6) | 1 (1) | 0 | |||
| Mucositis | 24 (25) | 59 (61) | 9 (9) | 0 | |||
| Hypoalbuminemia | 16 (17) | 61 (63) | 2 (2) | 0 | |||
| Abdominal pain | 5 (5) | 6 (6) | 1 (1) | 0 | |||
| Urinary tract/kidney | |||||||
| Creatinine elevation | 20 (21) | 4 (4) | 0 | 0 | |||
| Hemorrhagic cystitis | 0 | 2 (2) | 3 (3) | 0 | |||
| Skin | |||||||
| Hand-foot syndrome | 0 | 2 (2) | 2 (2) | 0 | |||
| Rash | 4 (4) | 1 (1) | 0 | 0 | |||
| Neurologic | |||||||
| Peripheral neuropathy | 4 (4) | 3 (3) | 0 | 0 | |||
| Headache | 4 (4) | 2 (2) | 0 | 0 | |||
| Mental status changes | 0 | 1 (1) | 0 | 0 | |||
| Seizures‡ | 1 (1) | 0 | 0 | 0 | |||
| Pulmonary/pleural | |||||||
| Pleural effusion | 1 (1) | 2 (2) | 0 | 0 | |||
| Pulmonary hemorrhage | 0 | 0 | 1 (1) | 0 | |||
| Pulmonary edema | 0 | 2 (2) | 0 | 0 | |||
| Electrolyte disturbance | 123 (100) | 42 (44) | 4 (4) | 0 | |||
| Hyperglycemia | 2 (2) | 6 (6) | 5 (5) | 0 | |||
| Cardiovascular | |||||||
| Hypertension | 4 (4) | 0 | 3 (3) | 0 | |||
| Hypotension | 2 (2) | 0 | 1 (1) | 0 | |||
| Arrhythmia | 2 (2) | 0 | 0 | 0 | |||
| Pericardial effusion | 0 | 0 | 1 (1) | 0 | |||
| Decreased LEVF | 0 | 0 | 2 (2) | 0 | |||
| Flulike symptoms/ATG-related symptoms | 3 (3) | 3 (3) | 1 (1) | 0 | |||
VOD indicates veno-occlusive disease of the liver; —, not applicable (all VOD cases were moderate); and ATG, antithymocyte globulin.
*Percentage of patients developing the side effect.
A third patient developed liver function abnormalities with ascites, without fulfilling all criteria for VOD
Patient presented with grand mal seizures, hypertensive crisis, and magnetic resonance imaging showing posterior cerebral edema related to tacrolimus, on day 50 after transplantation